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MRK PDUFA Date: KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv)

FDA decision (PDUFA) target 2026-08-17 · Merck & Company Inc. · Muscle-invasive bladder cancer (MIBC)

MRK run-up into the PDUFA (last ~120 days)

$123.93$109.18
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-08-17
Drug / candidateKEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv)
IndicationMuscle-invasive bladder cancer (MIBC)
CompanyMerck & Company Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04700124 · completed

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FAQ

When is the MRK PDUFA date?
The FDA PDUFA target date for MRK (Merck & Company Inc.) is 2026-08-17 for KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is MRK's drug KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv)?
KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) is Merck & Company Inc.'s candidate under FDA review for Muscle-invasive bladder cancer (MIBC).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.